Merck & Company Inc

Moderna stock popped 9% on Friday after the New York Times reported new details about an effort to accelerate cancer vaccine development, with investors seeing the mRNA biotech company in particular as a beneficiary. Other pharmaceutical stocks, including Pfizer, BioNTech, and Merck, also rose. According to the New York Times, the new initiative is a public-private partnership, similar to the effort that produced COVID-19 vaccines, that involves the National Institutes of Health, the NIH's nonprofit arm, researchers, pharmaceutical and biotech companies, advocacy groups, other nonprofits, and patients. Stacey Adam, a senior clinical officer at the NIH's foundation, told the New York Times that she expects the program to launch in December, and in 2024 the UK launched a similar program called the Cancer Vaccine Launch Pad. Moderna is viewed as a leader in mRNA cancer treatments, and the stock soared in August on positive results for a melanoma treatment developed with Merck; year to date, Moderna stock is up 627%.

Merck received FDA approval for WELIREG plus LENVIMA in adults with advanced renal cell carcinoma following prior PD-1/PD-L1 therapy. The approved regimen combines WELIREG at 120 mg once daily with LENVIMA at 20 mg once daily. Separately, Merck began a first-in-human Phase I trial using Cyprumed's oral peptide delivery platform for an undisclosed peptide candidate. The approval expands Merck's oncology portfolio beyond Keytruda, while the Cyprumed trial carries execution risk for the company's newer oral peptide technology.

The pheochromocytoma and paraganglioma market across the United States, EU4, the United Kingdom and Japan is projected to grow from approximately USD 300 million in 2025 to approximately USD 670 million by 2036, a CAGR of 7.3% during 2026-2036, according to a new ResearchAndMarkets.com report. The United States represented the largest regional market, generating approximately USD 200 million in 2025, and Merck's belzutifan, sold as WELIREG, is forecast to generate the highest PCPG therapy revenue in the United States by 2036. WELIREG, a selective HIF-2a inhibitor and the first oral targeted PCPG therapy, was approved in May 2025 for adult and pediatric patients aged 12 years and older with locally advanced, unresectable or metastatic PCPG, at a US list price of USD 31,162.50 per bottle of 90 tablets, or an estimated annual cost of USD 373,950. Approximately 4,900 incident PCPG cases were reported across the 7MM in 2025, including around 2,400 in the United States, and the report notes that pipeline rivals from Novartis, Jazz Pharmaceuticals and Perspective Therapeutics are advancing, including LUTATHERA, JZP3507 and VMT-a-NET.

Bristol Myers Squibb is counting on Reblozyl, the thalassemia drug it co-developed with Merck, to help drive top-line growth as legacy drug sales decline, with the treatment's sales nearing $1.3 billion in the first half of 2026, up 23% from the year-ago period. The drug's strong sales reflect solid uptake in first-line MDS-associated anemia, continued strength in the second-line setting and further penetration in the first-line RS-negative population. The FDA has accepted a supplemental biologics license application for Reblozyl with concomitant janus kinase inhibitor therapy in adult patients with myelofibrosis-associated anemia receiving red blood cell transfusions, supported by the late-stage INDEPENDENCE study, and granted a target action date of March 11, 2027. A phase III study called ELEMENT-MDS, evaluating Reblozyl in first-line non-transfusion dependent low or intermediate risk MDS associated anemia, is ongoing, with data expected in 2028. In the competitive landscape, Geron Corporation's Rytelo generated $57.5 million of revenues in the second quarter of 2026 and is expected to post 2026 sales of $220-$240 million, while Keros Therapeutics expects a $20 million development milestone payment from partner Takeda after dosing the first patient in the late-stage ELRiSE MF study.

Tempus announced an expanded, multi-year collaboration with Moderna and Merck to support the potential commercialization of intismeran autogene, also known as V940 or mRNA-4157, a potential first-in-class individualized neoantigen therapy being evaluated in combination with KEYTRUDA in patients with completely resected stage IIB-IV melanoma and other cancer types. Intismeran autogene is jointly developed by Moderna and Merck, known as MSD outside the United States and Canada, and the new collaboration builds on joint efforts initiated last year. Under the agreement, Tempus will manage the timely collection and transfer of tumor tissue and blood samples required for next-generation sequencing, and, subject to applicable regulatory approvals, will also provide NGS services to support the intismeran autogene design and manufacturing process. Financial terms of the collaboration were not disclosed. Moderna Chief Business Officer Said Francis said the partnership lets the company leverage Tempus's commercial footprint and advanced sequencing capabilities, while Jannie Oosthuizen, President of Global Oncology and MSD International, said such collaborations are helping build the infrastructure needed to bring individualized neoantigen therapies to patients at scale.

Personalized mRNA cancer vaccines are moving beyond their first major clinical success in melanoma into a broader test across harder-to-treat solid tumors, with the central investor question being whether a platform validated in one cancer type can deliver meaningful results across a wider range of tumor biology. Moderna announced Phase 3 melanoma data at ESMO alongside pancreatic cancer and NSCLC materials, outlining its multi-tumor development pathway for intismeran autogene, which it is developing in partnership with Merck across melanoma, pancreatic cancer, and non-small-cell lung cancer indications. BioNTech is the clearest pharmaceutical-scale competitor, with BNT113 targeting HPV16-positive head-and-neck cancer and autogene cevumeran, a Roche-partnered program, active in pancreatic cancer. Citi downgraded Moderna on valuation concerns following the melanoma result, arguing that implied sales and expansion expectations were aggressive, while Pfizer, BioNTech, and Moderna face ongoing litigation over mRNA technology patents. Evaxion announced two-year data for EVX-01, an AI-designed personalized peptide vaccine in advanced melanoma, illustrating competitive intensity around individualized immune therapies beyond the mRNA modality. Manufacturing complexity remains a constraint, as each patient requires tumor sequencing, neoantigen selection, and individualized production within a clinically useful timeframe.

Moderna Inc. ranked as the second top-performing stock in the US market in the third quarter, with shares surging 174.98 percent over the three months ending September. The rally was driven by news that its Intismeran Autogene combined with Merck's Keytruda achieved the primary endpoint of recurrence-free survival and the secondary target of distant metastasis-free survival in a late-stage clinical trial, marking the first positive readout from a phase 3 trial combining an mRNA-based cancer treatment with individualized neoantigen therapy and the first late-stage phase to show a clinically meaningful improvement over Keytruda alone. Melanoma, the target indication, is expected to increase by 112,000 cases by the end of the year, including an estimated 8,500 deaths, after some 330,000 cases were diagnosed globally in 2022. In August, Moderna received FDA approval of its biologics license application for the 2026 to 2027 formulas of its Spikevax and mNEXSPIKE COVID-19 vaccines. The vaccine maker is set to join the Nasdaq 100 index on Friday, October 9, replacing Warner Bros. Discovery Inc., which is set to merge with Paramount Skydance Corp. on Tuesday, October 6.

CanSino surged to the daily limit up on the last trading day before the National Day holiday, with its share price breaking through the previous consolidation range and reaching a new stage high since April 2023, while its H shares also moved higher in tandem. On October 1, CanSino issued a stock movement announcement stating that the company had noted recent market developments regarding mRNA technology, as well as the release or planned disclosure of overseas clinical stage data for mRNA cancer vaccines. CanSino made clear that the mRNA platform is one of the technology platforms in its portfolio, and that the company is developing preventive mRNA vaccines and therapeutic biologics, as well as related delivery systems. In the therapeutic area, it is advancing research and development of mRNA vaccines for indications including glioblastoma, rhabdomyosarcoma, and cervical cancer, as well as the development of In Vivo CAR-related therapies, all of which are currently in early stages. In August this year, Merck and Moderna jointly announced that their personalized messenger RNA cancer vaccine met its primary endpoint in a Phase III trial, making it the first therapeutic vaccine proven effective in a large-scale Phase III clinical trial globally. On August 25, CanSino's official WeChat account announced that its subsidiary CanSino Shanghai Biologics had formally signed a strategic cooperation framework agreement with Depush Hangzhou Biotechnology for the joint development of personalized therapeutic mRNA cancer vaccines. The two parties will jointly advance the research, development, and commercialization of personalized therapeutic mRNA cancer vaccines, with a global focus on gastrointestinal solid tumors and rare tumor treatment areas. It should be noted that CanSino's entire mRNA product line has not yet moved beyond the early research and development stage, and innovative drug development carries multiple uncertainties including technical failure, clinical results falling short of expectations, and approval delays, while competition in the domestic mRNA vaccine sector is also becoming increasingly intense.

Merck announced that its phase IIb MK-7240-012 study of tulisokibart in patients with moderate to severe hidradenitis suppurativa met its primary endpoint. In the trial, 72% of patients on the high dose of tulisokibart, 480 mg every two weeks, and 64% on the medium dose, 480 mg every four weeks, achieved Hidradenitis Suppurativa Clinical Response 50 at week 16, compared with 35% on placebo. In an exploratory analysis, 52% of patients on the low dose, 240 mg every four weeks, achieved HiSCR50, a 17% improvement over placebo. Tulisokibart also showed numerical improvements on the non-ranked key secondary endpoint of HiSCR75 at week 16, with response rates of 41% for the high-dose group, 40% for the medium-dose group and 29% for the low-dose group, versus 15% for placebo. Merck said the results represent the first positive phase II data for an anti-TL1A monoclonal antibody in dermatology and that it plans to advance tulisokibart into phase III development for hidradenitis suppurativa; the candidate, added through the 2023 acquisition of Prometheus Biosciences, is also being studied across six indications, including phase III trials in ulcerative colitis and Crohn's disease.

Merck reported second-quarter revenues of $16.61 billion, up 5.1% year on year and 2.1% above analysts' expectations, as the nine branded pharmaceuticals stocks tracked by the report collectively beat consensus revenue estimates by 6.6%. The company beat analysts' EPS estimates but missed analysts' full-year EPS guidance estimates, and its stock is up 16.2% since reporting, trading at $148.50. Among peers, Corcept Therapeutics posted the group's best quarter with revenues of $256.1 million, up 31.7% year on year and 21.6% above expectations, while Zoetis delivered the weakest performance with revenues of $2.47 billion, flat year on year and 1.5% below expectations. Collegium Pharmaceutical reported revenues of $199.9 million, up 6.3% year on year but 0.7% below expectations, and Pfizer reported revenues of $15.03 billion, up 2.6% year on year and 4.4% above expectations. As a group, share prices of the tracked companies have held steady, up 2.1% on average since the latest earnings results.

MSD has initiated a Phase I clinical trial of one of its proprietary drug candidates formulated using Cyprumed GmbH's licensed oral drug delivery technology, marking the first Cyprumed technology program to enter human clinical development and triggering a milestone payment from MSD. The study follows the two companies' Non-Exclusive License and Option Agreement announced in April 2025 to develop oral formulations of MSD's peptides using Cyprumed's technology. Under that agreement, Cyprumed is eligible to receive up to $493 million in upfront, development, regulatory and net sales milestones associated with products developed under the collaboration. Cyprumed CEO Florian Föger called the trial start an important milestone and a strong validation of the company's technology, noting its goal of overcoming challenges such as the impact of food on drug absorption. Cyprumed is a drug delivery technology company based in Innsbruck, Austria, focused on oral administration of therapeutic peptides including GLP-1 analogues, macrocycles and mini-proteins.

China's innovative drug industry has welcomed another major licensing deal. Shanghai Sprout and Merck jointly announced a global exclusive licensing agreement for SPR2015, a preclinical oral KRAS G12D (ON) inhibitor, with a potential total value of $2.13 billion, including an upfront payment of $400 million, with the remainder tied to development and commercialization milestones. Meanwhile, Summit Therapeutics, the overseas partner of Akeso, announced that AstraZeneca will make a $2 billion strategic equity investment in Summit and intends to lead clinical exploration of Akeso's first-in-class tumor immunotherapy 2.0 cornerstone drug ivonescimab in combination with AstraZeneca's Sonesitatug Vedotin for treating multiple gastrointestinal tumors. The two parties also signed a memorandum of understanding to further advance clinical exploration of ivonescimab combined with a range of AstraZeneca antibody-drug conjugates and other anti-tumor drugs. Boosted by the news, as of 10:01 a.m. on September 29, 2026, the STAR Market Biotech ETF managed by Penghua Fund, with ticker 588250, saw its underlying index, the SSE STAR Market Biomedical Index with code 000683, rise 1.10%. Among constituents, InventisBio rose 5.16%, Micro-Tech Nanjing rose 3.84%, Hotgen Biotech rose 3.13%, and Huiyu Pharmaceutical and Yound Biotechnology followed the gains. China Securities pointed out that the medical device sector has reached an inflection point in 2026, and stocks with improving performance are expected to see dual recovery in valuation and earnings. High-value consumables and in-vitro diagnostics segments are expected to gradually clear the impact of centralized procurement price cuts in the second half of the year, and leaders in niche tracks will accelerate growth.

Mission Bio announced that Merck & Co. and Incyte will each present new data generated using its Assay Services and Tapestri Platform at the 16th World Clinical Biomarkers & Companion Diagnostics Summit, alongside a third presentation from Mission Bio itself featuring new clinical data in acute myeloid leukemia. Merck scientist Sydney Hart will present functional genomics findings from a targeted DNA and RNA single-cell assay built with Mission Bio's Assay Services team to study how CRISPR-edited genetic variants affect immune cell function in autoimmune and inflammatory disease, work that links target validation to drug development decision-making. Incyte's Erin Crowgey will present new single-cell clinical data on INCA033989, a monoclonal antibody targeting mutant calreticulin-positive cells in essential thrombocythemia and myelofibrosis, generated with a custom Tapestri assay measuring 46 proteins and 37 genes in the same cell, showing depletion of mutant CALR-positive cells and repopulation by wild-type cells with relevant clinical improvements. Mission Bio Chief Medical Officer Zivjena Vucetic will present clinical study data showing single-cell multiomics achieved 93% sensitivity for measurable residual disease in AML compared to 43% for flow cytometry and 71% for other molecular methods, with additional evidence supporting more accurate stratification of relapse-free survival. The three presentations illustrate how single-cell multiomics connects genetic variation to cellular function, characterizes treatment response in individual cell populations, and identifies residual disease with greater resolution across drug development pipelines.

Merck's CAPVAXIVE has been included in Ontario's publicly funded adult pneumococcal immunization program, the company announced. The vaccine, approved by Health Canada for adults 18 and older, helps prevent invasive pneumococcal disease caused by 21 Streptococcus pneumoniae serotypes, including serious infections such as sepsis, meningitis, and bacteremic pneumonia. Canadian surveillance data from 2019 to 2023 showed that the serotypes included in CAPVAXIVE accounted for approximately 65% of IPD cases in adults aged 18 to 49, approximately 74% of cases in adults aged 50 to 64, and approximately 80% of cases in adults aged 65 and older, based on data from the Public Health Agency of Canada. Matthew Thornhill, Executive Director of the Vaccines and HIV Business Unit at Merck Canada, said Ontario's decision reflects the importance of ensuring immunization programs continue to respond to changing public health needs and disease trends. In Canada, approximately 3,000 cases of invasive pneumococcal disease are reported each year.

Merck has entered into an exclusive global license agreement with SciBrunch Therapeutics for SPR2015, an investigational preclinical oral KRAS G12D (ON) inhibitor. Under the deal, SciBrunch grants Merck exclusive rights to develop, manufacture and commercialize SPR2015 worldwide, receiving a $400 million upfront payment plus milestone payments tied to development, commercialization and other activities across multiple indications, for a total potential aggregate value of $2.13 billion. The transaction has closed, and Merck will record a pre-tax charge of $400 million, or approximately $0.13 per share, in its GAAP and non-GAAP third-quarter 2026 results. SciBrunch founder, chairman and chief executive Tao Hu said the agreement validates the company's R&D platform and the potential of SPR2015 against unmet needs in pancreatic, colorectal, lung and other major malignant tumors. BofA Securities acted as exclusive financial advisor to SciBrunch.

Moderna and Merck reported that their Phase 3 INTerpath-001 trial of personalized cancer vaccine intismeran autogene plus Keytruda met its primary endpoint in melanoma, with full data presented earlier this month at the European Society for Medical Oncology Congress 2026. Moderna is also in talks with Middle East partners about potential investment and manufacturing cooperation, pairing its mRNA oncology push with efforts to extend its geographic footprint and industrial capabilities beyond its original COVID-19 franchise. The company recently won FDA approval of mFlusiva, its mRNA flu vaccine for adults 50 and older, underscoring its push to build a non-seasonal respiratory portfolio. Moderna's narrative projects $4.5 billion revenue and $782.2 million earnings by 2029, yielding a $119.56 fair value, a 40% downside to its current price, while some of the most optimistic analysts assume revenue could reach about US$8.5 billion and earnings turn positive by 2029.

Merck announced positive top-line data from the phase IIb/III BRUNELLO study of its investigational candidate remigromig, also known as MK-3000 and formerly EYE103, in adults with diabetic macular edema. The study met its primary endpoint, with both the 0.5-mg and 0.8-mg doses of remigromig demonstrating non-inferiority to ranibizumab 0.5-mg for mean change from baseline in best-corrected visual acuity at week 52, and both doses were generally well tolerated. Higher rates of proliferative diabetic retinopathy, vitreous hemorrhage and treatment discontinuations due to adverse effects were seen in the remigromig groups compared with ranibizumab, and Merck said further analyses are underway to characterize these findings. Remigromig is a first-in-class tetravalent, tri-specific antibody designed to activate the Wnt pathway, and Merck noted it is the first new mechanism of action in 20 years to achieve phase III results non-inferior to anti-VEGF therapy. BRUNELLO is the first of two phase IIb/III studies of remigromig in DME, alongside the ongoing pivotal BAROLO study in DME and the phase II SUPER TUSCAN study in neovascular age-related macular degeneration and retinal vein occlusion, with year-one results planned for the American Academy of Ophthalmology Annual Meeting in October 2026.

The U.S. Food and Drug Administration has approved the dual oral regimen of WELIREG (belzutifan) plus LENVIMA (lenvatinib) for the treatment of adult patients with advanced renal cell carcinoma with a clear cell component following a PD-1 or PD-L1 inhibitor, Merck and Eisai announced. The approval is based on data from the Phase 3 LITESPARK-011 trial, in which WELIREG plus LENVIMA reduced the risk of disease progression or death by 26% compared to cabozantinib, with a median progression-free survival of 14.6 months versus 10.6 months. The combination also showed an objective response rate of 53% versus 40% for cabozantinib, while overall survival did not meet statistical significance at the final analysis. WELIREG plus LENVIMA is the first approved combination of a HIF-2 alpha inhibitor and a multi-targeted VEGFR-TKI for these patients, and the companies said the LITESPARK-011 results will be presented at the upcoming European Society for Medical Oncology Congress 2026 in Madrid, Spain.

Merck won an FDA label update adding HYPERION trial data for adults recently diagnosed with pulmonary arterial hypertension, sending shares up about 1.0% to $149.56 at 11.19am ET on Thursday. In the 320-person trial, Winrevair plus background therapy cut the risk of clinical worsening by 76% versus placebo, with first events occurring in 10.6% of treated patients compared with 36.9% of those receiving placebo. The broader label could support earlier use of the therapy, though commercial gains still hinge on diagnosis, insurance coverage and how long patients stay on treatment. Merck shares trade at $149.56, 23.8% above GuruFocus' $120.80 GF Value estimate.

Inhibrx Biosciences said its experimental cancer drug INBRX-106 combined with Merck's Keytruda produced a confirmed objective response rate of 48.3% versus 26.5% for Keytruda alone in the Phase 2 portion of its HexAgon study in treatment-naive, PD-L1-positive metastatic or unresectable recurrent head and neck squamous cell carcinoma. The study enrolled 68 patients, with 63 evaluable for the primary endpoint, and four patients, or 13.8%, on the combination achieved a complete response versus none on Keytruda alone. Median progression-free survival was 9.6 months for the combination versus 4.9 months for Keytruda alone as of the August 19 data cutoff, and among 10 evaluable HPV-positive patients the confirmed response rate was 80% versus 33.3% among nine patients on Keytruda alone. Inhibrx plans to add approximately 50 HPV-positive oropharyngeal cancer patients to the Phase 2 study to support a potential accelerated regulatory pathway, estimating the U.S. could have approximately 30,000 HPV-positive head and neck cancer patients by 2029, including around 6,000 first-line recurrent patients, representing a $1 billion annual sales opportunity. Despite the data, Inhibrx shares fell 8.8% to $110.45, a move CEO Mark Lappe told Reuters the company could not explain, while Stifel analyst Dara Azar called the results competitive against the difficult OX40 target.

The CDC has acknowledged one of the four measles-related deaths reported by Pennsylvania, ending weeks of resistance by the agency. The CDC's "Measles Cases and Outbreaks" page lists 3,471 cases nationwide as of Sept. 18, compared with 2,289 in all of 2025. Of the 3,471 cases, 9 percent, or 301 individuals, have resulted in hospitalizations, and 95 percent of all cases were in people not vaccinated with the MMR shot, which Merck and GSK market in the U.S. Pennsylvania is the hardest-hit state, with 792 cases as of Sept. 21. Pennsylvania Secretary of Health Debra Bogen recently asked the CDC for rapid-response assistance known as Epi-Aid, but only if the agency recognizes the state's four measles-associated deaths.

Moderna shares rose another 5% to $181.51 on Tuesday morning, extending a 516% year-to-date gain, as investors position ahead of a late-October readout for the company's personalized cancer therapy. Moderna said detailed Phase 3 results for intismeran autogene, developed with Merck, will be presented at the European Society for Medical Oncology Congress in a Presidential Symposium on October 24. The data come from the INTerpath-001 study, which enrolled 1,137 participants and tested intismeran plus Merck's Keytruda against Keytruda alone in high-risk melanoma patients whose tumors had been surgically removed; Moderna reported last month that the trial met its primary endpoint of recurrence-free survival and a key secondary endpoint of distant metastasis-free survival, with both companies calling the improvements statistically significant and clinically meaningful, but releasing no underlying numbers. BioNTech, the other large messenger RNA developer, is up just 5% year to date at $100.42, a contrast that suggests the market is pricing an intismeran-specific outcome rather than a broad re-rating of the mRNA platform. Moderna and Merck are running intismeran across nine mid-stage and late-stage studies in other tumor types, including non-small cell lung cancer, bladder cancer and renal cell carcinoma, so the October 24 hazard ratios and survival curves carry binary risk for a stock that has rallied on a top-line conclusion rather than a dataset.

Merck received Japanese approval for KEYTRUDA QLEX, also known as KEYJECT, its first subcutaneous formulation of KEYTRUDA, cleared for all existing local indications in the country. The new subcutaneous version offers an alternative to intravenous dosing and is aimed at faster administration for patients and clinicians. The approval broadens Merck's oncology treatment options in Japan, a key international market for its immunotherapy portfolio, and supports the view that the company can deepen the KEYTRUDA franchise rather than rely on a single route of administration. The article notes that convenience-driven launches do not directly address questions about pricing pressure, GARDASIL softness, or eventual KEYTRUDA loss of exclusivity that analysts have already flagged as risks. The balance still appears positive for the Merck narrative, but only if subcutaneous use contributes to the company's wider plan for more than 20 pipeline growth drivers.

Merck announced that the U.S. Food and Drug Administration has approved an update to the U.S. product label for WINREVAIR, also known as sotatercept-csrk, for injection at 45mg and 60mg, based on the Phase 3 HYPERION trial. In HYPERION, which enrolled 320 adults newly diagnosed with pulmonary arterial hypertension at intermediate to high risk of disease progression, adding WINREVAIR to background therapy reduced the risk of clinical worsening events by 76% compared with placebo, with a hazard ratio of 0.24 and a 95% confidence interval of 0.14 to 0.41 and a p value below 0.0001. A first clinical worsening event occurred in 10.6% of patients who received WINREVAIR, or 17 of 160, versus 36.9%, or 59 of 160, of those on placebo, and the mean time since PAH diagnosis was 7.2 months. The label update also adds safety information, including monitoring of hemoglobin and platelets before each dose for the first 5 doses, and notes that the most common adverse reactions in HYPERION were epistaxis at 31.9% versus 6.9%, telangiectasia at 26.3% versus 11.3% and increased hemoglobin at 11.3% versus 1.3%. Separately, Merck said the European Respiratory Society this month published clinical guidelines for the treatment of PAH that are the first formal clinical guidelines to include WINREVAIR, giving it a strong recommendation and grading the certainty of evidence as high.

Pfizer's decade-long streak of annual dividend increases has stalled, with its quarterly payout holding at $0.43 through the September 1, 2026 payment after the January 2026 ex-dividend date matched the prior four quarters instead of rising. The 6.20% yield remains covered by reaffirmed 2026 adjusted diluted EPS guidance of $2.80 to $3.00 against a run-rate $1.72 annual payout, and Q1 2026 adjusted EPS of $0.75 beat consensus for a fifth consecutive quarter above estimates. Cash outflow is real, with $2.4 billion in dividends paid in Q1 alone and $9.8 billion for full-year 2025, while Pfizer completed no buybacks in 2025 and anticipates none in 2026 despite $3.3 billion of unused authorization. On the August 4, 2026 call, incoming interim CFO Cecile Guegan said Pfizer would keep maintaining and over the long term growing the dividend, and Chairman and CEO Albert Bourla said the dividend will be maintained and eventually start growing again after the loss-of-exclusivity period. Peers have not frozen their payouts: Merck raised its quarterly from $0.81 to $0.85 starting with the December 2025 ex-date, and Bristol-Myers Squibb nudged its payout from $0.62 to $0.63 with the January 2026 ex-date. The pressure behind the pause is visible in the mix, with Comirnaty down 59% and Paxlovid down 62% in Q1 2026 and roughly $1.5 billion in additional generic and biosimilar headwind guided for the year, partly offset by launched and acquired products growing 22% operationally and Vyndamax exclusivity now running to June 2031.

Merck announced that the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval of KEYTRUDA, the company's anti-PD-1 therapy, in combination with Padcev as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment for adults with resectable muscle-invasive bladder cancer. The recommendation, which also includes KEYTRUDA SC, known as KEYTRUDA QLEX in the U.S., will now be reviewed by the European Commission for marketing authorization in the European Union, Iceland, Liechtenstein and Norway, with a final decision expected by the fourth quarter of 2026. The opinion is based on results from the Phase 3 KEYNOTE-B15 trial, also known as EV-304, conducted in collaboration with Pfizer and Astellas, in which the perioperative regimen reduced the risk of event-free survival events by 47% (HR=0.53) and the risk of death by 35% (HR=0.65) versus neoadjuvant chemotherapy and surgery in cisplatin-eligible patients, while pathologic complete response reached 55.8% versus 32.5%. If approved, KEYTRUDA plus Padcev would become the first and only PD-1 inhibitor plus antibody-drug conjugate regimen in the European Union for patients with MIBC regardless of cisplatin eligibility. In June 2026, the European Commission approved the combination for cisplatin-ineligible adults with resectable MIBC based on the Phase 3 KEYNOTE-905 trial, and in July 2026 the U.S. Food and Drug Administration approved it for adults with MIBC regardless of cisplatin eligibility based on KEYNOTE-B15.

Merck shares rose approximately 1.0% to $146.39 Thursday as the pharmaceutical and oncology heavyweight entered the next era of commercial space research, with its blockbuster cancer drug Keytruda already benefiting from work conducted in orbit. Research aboard the International Space Station helped scientists better understand protein crystallization, contributing to the development of a faster subcutaneous formulation of Keytruda, and NASA's research overview explains that microgravity can produce larger and more orderly protein crystals, potentially giving researchers clearer structural information. As the ISS approaches retirement, commercial stations could offer drugmakers dedicated equipment and more predictable research schedules, although regulators still lack a purpose-built approval framework for medicines manufactured in space. The commercial stakes are already enormous: Keytruda generated about $8.37 billion of Merck's latest $16.61 billion quarter, roughly half of total revenue, while the subcutaneous version contributed $463 million, or around 5.5% of Keytruda sales. At $146.39, Merck trades 21.85% above its GF Value estimate of $120.14, signaling that investors are already paying a meaningful premium to the model's estimate of fair value.

Immunocore announced it has reached target enrollment of 540 patients in the phase III TEBE-AM study, which is evaluating its sole marketed drug, Kimmtrak, in patients with second-line or later advanced melanoma. The randomized, registrational trial is testing Kimmtrak as a monotherapy and in combination with Merck's PD-L1 inhibitor Keytruda versus investigator's choice in HLA-A*02:01-positive patients whose disease progressed after prior therapy, with overall survival as the primary endpoint. Immunocore expects to report top-line overall survival data from TEBE-AM as early as the end of 2026, and management says Kimmtrak could address a significant unmet need among up to 4,000 HLA-A*02:01-positive patients with previously treated advanced melanoma in the post-PD1 setting. Kimmtrak is currently approved for unresectable or metastatic uveal melanoma, and its sales rose 16% year over year to $222.6 million in the first half of 2026. Merck recorded $16.40 billion in Keytruda sales in the first half of 2026, up 4.2% year over year.

Perspective Therapeutics has signed a clinical trial collaboration and supply agreement with Merck to evaluate its targeted alpha-particle therapy [212Pb]PSV359 in combination with Keytruda, Merck's anti-PD-1 therapy, in patients with FAP-α-positive solid tumors. The combination will be tested under an amendment to Perspective's ongoing Phase 1/2a study of [212Pb]PSV359 in certain types of non-small cell lung cancer and colorectal cancer that express fibroblast activation protein alpha, under clinicaltrials.gov identifier NCT06710756. Perspective is sponsoring the study and Merck is providing pembrolizumab at no cost, with enrollment already completed in the first three monotherapy dose cohorts. Markus Puhlmann, Perspective's Chief Medical Officer, said FAP-α is associated with the majority of solid tumors and a tumor microenvironment historically characterized by poor drug penetration and immune suppression or exclusion, and that combining targeted radiopharmaceutical treatment with a well-established immune checkpoint inhibitor may reshape the tumor environment and improve outcomes for patients with advanced FAP-α-positive solid tumors.

Merck & Co. reported second-quarter worldwide sales of $16.6 billion, with its oncology franchise led by intravenous Keytruda and the subcutaneous formulation Keytruda QLEX generating $8.4 billion in quarterly revenue. The pulmonary arterial hypertension treatment Winrevair surged 75% to reach $588 million, and management raised its full-year 2026 sales guidance to a range between $66.3 billion and $67.3 billion. The company faces the loss of exclusivity for Keytruda toward the end of 2028, pushing it to fund and acquire new pipeline assets, including a personalized mRNA cancer vaccine collaboration with Moderna. According to Insider Monkey's database, 101 hedge funds held a stake in the company during the second quarter, up from 98 in the prior quarter, while short interest sits at just 0.99% of the float. Fisher Asset Management maintained the top position with 38.5 million shares, increasing its holdings by 46%.